Skin Conductance in Ventilated Preterms | NCT07568418

Studies
Skin Conductance in Ventilated Preterms

NCT07568418

Sponsor

Uppsala University Hospital

Status

Recruiting

Last Update Posted

May 5, 2026Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Mechanical Ventilation
Pain
Skin to Skin Care
Kangaroo Mother Care

Interventions

Skin Conductance Measurement

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2025Actual

Primary Completion Date

May 30, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Apr 21, 2026

First Submission Date that Met QC Criteria

Apr 30, 2026

First Posted Date

May 5, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2026

Last Update Posted Date

May 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn more about the pain and stress experienced by newborn infants receiving mechanical ventilation (breathing through a machine).

The main questions it aims to answer are:

Do different ventilator settings (modi) cause different degrees of pain and stress?
Can skin conductance measurement be used to evaluate the pain and stress caused by mechanical ventilation in newborns?
Can skin-to-skin care alleviate the stress caused by mechanical ventilation?

Participants will be monitored according to clinical protocol with the addition of electrodes placed on the infant's foot, measuring changes in skin conductance.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Skin Conductance Measurement	Device	Objectifying stress by measuring changes in skin conductance using electrodes placed on the infants' feet.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in skin conductance	Changes in skin conductance measured in micro Siemens	From the time on one ventilator setting to another, on average about two weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Need for mechanical ventilation

Exclusion Criteria:

Other distracting painful conditions
Facial malformation or neuromuscular disease, not allowing regular visual pain assessment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Weeks

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Johanna T Walan, Student Researcher	Contact	+46704184255		johanna.walan@uu.se

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uppsala University Children's Hospital	Recruiting	Uppsala	Uppland	75185	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided